Tasigna

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Tasigna Capsules

PATIENT INFORMATION

TASIGNA®
(ta-sig-na)
(nilotinib) Capsules

Read this Medication Guide before you start taking
Tasigna and each time you get a refill. There may be new information. This
information does not take the place of talking to your healthcare provider
about your medical condition or treatment.

What is the most important information I should know
about Tasigna?

Tasigna can cause a possible life-threatening heart
problem called QTc prolongation. QTc prolongation causes an irregular
heartbeat, which may lead to sudden death.

Your healthcare provider should check the electrical
activity of your heart with a test called an electrocardiogram (ECG):

before starting Tasigna

7 days after starting Tasigna

with any dose changes

regularly during Tasigna treatment

You may lower your chances for having QTc prolongation
with Tasigna if you:

Avoid taking other medicines or supplements with Tasigna
that can also cause QTc prolongation.

Tasigna can interact with many medicines and supplements
and increase your chance for serious and life-threatening side effects.

Do not take any other medicine while taking Tasigna
unless your healthcare provider tells you it is okay to do so.

If you cannot swallow Tasigna capsules whole, you may
open the Tasigna capsule and sprinkle the contents of each capsule in 1
teaspoon of applesauce (puréed apple). Swallow the mixture right away (within
15 minutes). For more information, see “How should I take Tasigna?”

Call your healthcare provider right away if you feel
lightheaded, faint, or have an irregular heartbeat while taking Tasigna. These
can be symptoms of QTc prolongation.

a severe problem with lactose (milk sugar) or other
sugars. Tasigna capsules contain lactose. Most patients who have mild or
moderate lactose intolerance can take Tasigna.

have bleeding problems

had a surgical procedure involving the removal of the
entire stomach (total gastrectomy)

are pregnant or plan to become pregnant. Tasigna may harm
your unborn baby. If you are able to become pregnant, you should use effective
birth control during treatment with Tasigna. Talk to your healthcare provider
about the best birth control methods to prevent pregnancy while you are taking
Tasigna.

are breastfeeding or plan to breastfeed. It is not known
if Tasigna passes into your breast milk. You and your healthcare provider
should decide if you will take Tasigna or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines
you take, including prescription and over-the-counter medicines, vitamins
and herbal supplements.

If you need to take antacids (medicines to treat
heartburn) do not take them at the same time that you take Tasigna. If you
take:

a medicine to block the amount of acid produced in the
stomach (H2 blocker): Take these medicines about 10 hours before you
take Tasigna, or about 2 hours after you take Tasigna.

an antacid that contains aluminum hydroxide, magnesium
hydroxide, and simethicone to reduce the amount of acid in the stomach: Take
these medicines about 2 hours before or about 2 hours after you take
Tasigna.

Tasigna can interact with many medicines and supplements
and increase your chance for serious and life-threatening side effects. See “What
is the most important information I should know about Tasigna?”

Know the medicines you take. Keep a list of them and show
it to your healthcare provider and pharmacist when you get a new medicine.

Open the Tasigna capsules and sprinkle the contents in 1
teaspoon of applesauce (puréed apple).

Do not use more than 1 teaspoon of applesauce.

Only use applesauce. Do not sprinkle Tasigna onto other
foods.

Swallow the mixture right away (within 15 minutes).

Do not drink grapefruit juice, eat grapefruit, or take
supplements containing grapefruit extract at any time during treatment. See “What
is the most important information I should know about Tasigna?”

If you miss a dose, just take your next dose at your regular
time. Do not take 2 doses at the same time to make up for a missed dose.

If you take too much Tasigna, call your healthcare
provider or poison control center right away. Symptoms may include vomiting and
drowsiness. During treatment with Tasigna your healthcare provider will do
tests to check for side effects and to see how well Tasigna is working for you.
The tests will check your:

heart

blood cells (white blood cells, red blood cells, and
platelets). Your blood cells should be checked every 2 weeks for the first 2
months and then monthly.

Your healthcare provider may change your dose. Your
healthcare provider may have you stop Tasigna for some time or lower your dose
if you have side effects with it.

What are the possible side effects of Tasigna?

Tasigna may cause serious side effects including:

See “What is the most important information I should
know about Tasigna?”

Decreased blood flow to the leg, heart, or brain. People
who have recently been diagnosed with Ph+ CML and take Tasigna may develop
decreased blood flow to the leg, the heart, or brain.
Get medical help right away if you suddenly develop any of the following
symptoms:

Tell your healthcare provider if you have any side effect
that bothers you or does not go away.

These are not all of the possible side effects of
Tasigna. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1800-FDA-1088.

How should I store Tasigna?

Store Tasigna at room temperature between 68°F to 77°F
(20°C to 25°C).

Safely throw away medicine that is out of date or no
longer needed.

Keep Tasigna and all medicines out of the reach of
children.

General information about Tasigna

Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use Tasigna for a condition for
which it was not prescribed. Do not give Tasigna to other people, even if they
have the same problem you have. It may harm them.

This Medication Guide summarizes the most important
information about Tasigna. If you would like more information, talk with your
healthcare provider. You can ask your healthcare provider or pharmacist for
information about Tasigna that is written for health professionals.

For more information, go to www.us.tasigna.com or call
1-866-411-8274.